Lead MedTech customers through their regulatory transformation via implementation of Veeva RIM applications
Partner with customer SMEs and business leaders to analyze, develop, and implement regulatory processes that solve business problems and support business needs with Veeva RIM (Submissions, Submissions Archive, Registrations, and Publishing)
Analyze and document current state business processes, identifying pain points and gaps in process or system functionality
Define roll-out strategies for deployment of Veeva RIM across global regulatory teams
Serve as the primary customer liaison managing communication between project team, customer, and other internal stakeholders
Represent Professional Services across multiple engagements and workstreams (solution design and configuration, data migration, systems integration)
Mentor project team and junior consultants in the Professional Services organization
Translate customer requirements into solution design and define global strategies to deploy cloud-based regulatory solutions across the enterprise
Requirements
8+ years of experience implementing regulatory information management systems and processes (e.g., Registration Data Tracking Systems, Submission systems)
Working knowledge of life sciences compliance, regulatory guidance, day in the life business processes
Ability to quickly understand business use cases and create corresponding process and business improvements aligned with Preferred Vault Practices
Experience implementing software systems with the ability to comprehend and translate business requirements into solution designs
Proven expertise in customer leadership and mentoring of team members
Demonstrated stakeholder management, critical thinking, and ability to conduct complex and technical communications to varied audiences
Ability to travel up to 50%
Nice to have: Direct experience with systems such as Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, IQVIA, Trackwise
Nice to have: Consulting experience with a major software vendor or process management consulting group
Nice to have: Regulatory Affairs, Regulatory Operations, or Submissions Management background
Nice to have: Life Science, computer science, biochemical or mechanical engineering or related degree
Nice to have: SaaS/Cloud experience
Benefits
Medical, dental, vision, and basic life insurance
Flexible PTO and company paid holidays
Retirement programs
1% charitable giving program
Work Anywhere flexibility to work from home or in the office
Applicant Tracking System Keywords
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